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U.S. Department of Health and Human Services

Class 2 Device Recall gastrostomy kits

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 Class 2 Device Recall gastrostomy kitssee related information
Date Initiated by FirmNovember 12, 2004
Date PostedDecember 21, 2004
Recall Status1 Terminated 3 on February 21, 2007
Recall NumberZ-0332-05
Recall Event ID 30433
510(K)NumberK884275 
Product Classification unknown device name - Product Code LNO
Product18 French Ross Introducer Complete Gastrostomy Kit with Brown/Mueller T-Fastener Set (list # 50190).
Code Information Lots: 02565GZ00, 03600GZ00, 04643GZ00, 05676GZ00, 06719GZOO, 10829GZ00, 10860GZ00, 11893GZ00, 12943GZ00, 13960GZ00, 14011GZ00, 14052GZ00, 15089GZ00, 16134GZ00, 16143GZ00, 18206GZ00, 84569GZ00, 86700GZ00, 88826GZ00, 89942GZ00, 90015GZ00, 91105GZ00, 92199GZ00, 93261GZ00, 94322GZ00, 95410GZ00, 96470GZ00.
FEI Number 1527460
Recalling Firm/
Manufacturer		 Abbott Laboratories
6550 Singletree Dr
Columbus OH 43229-1119
For Additional Information ContactRandal P. McKay
614-624-3688
Manufacturer Reason
for Recall		Gastrostomy and Jejunostomy primary placement kits which may contain components that may not have been adequately sterilized, were distributed.
FDA Determined
Cause 2		Other
ActionThe recalling firm notified customers by letter, dated 11/12/04.
Quantity in Commerce16,538 gastrostomy kits.
DistributionThe product was distributed throughout the United States and to foreign consignees located in Australia, Korea, Thailand, Venezuela, and Puerto Rico.
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database510(K)s with Product Code = LNO
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